SPRAZOLE-40 ESOMEPRAZOLE GASTRO RESISTANT 40 MG TABLETS [SIN16685P]

Product Info

SPRAZOLE-40 ESOMEPRAZOLE GASTRO RESISTANT 40 MG TABLETS

[SIN16685P]

4.1 Therapeutic indications

Esomeprazole tablets are indicated for:

Gastroesophageal Reflux Disease (GERD)

• Treatment of erosive reflux esophagitis.

• Long-term management of patients with healed esophagitis to prevent relapse.

• Symptomatic treatment of gastroesophageal reflux disease (GERD).

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

• Healing of Helicobacter pylori associated duodenal ulcer and

• Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Patients requiring continued NSAID therapy

• Healing of gastric ulcers associated with NSAID therapy.

• Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months.

Patients requiring continued low dose aspirin (75–325 mg) therapy

• Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy, in patients at risk.

Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole IV solution by intravenous infusion.

Treatment of Zollinger Ellison Syndrome

4.2 Posology and method of administration

The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.

For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.

For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested.

For preparation and administration instructions see “Instructions for use and handling” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Adults and adolescents from the age of 12 years

Gastroesophageal Reflux Disease (GERD)

• Treatment of erosive reflux esophagitis:
  40 mg once daily for 4 weeks.

  An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

• Long-term management of patients with healed esophagitis to prevent relapse:
  20 mg once daily.

  Controlled studies in adolescence do not extend beyond 8 weeks. Therefore, physicians who elect to use Esomeprazole in adolescents for extended periods should periodically re- evaluate the long-term risks and benefits of the drug for the individual patient.

• Symptomatic treatment of gastroesophageal reflux disease (GERD):

  20 mg once daily in patients without esophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on demand regimen taking 20 mg once daily, when needed. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on demand regimen is not recommended.

Adults

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

• Healing of Helicobacter pylori associated duodenal ulcer:
  20 mg Esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days

• Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers:
  20 mg Esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.
The posology recommendation for esomeprazole is the following:
20 mg twice daily for one week.

Patients requiring continued NSAID therapy

• Healing of gastric ulcers associated with NSAID therapy:
  The usual dose is 20 mg once daily. The treatment duration is 4–8 weeks.

• Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk:
  20 mg once daily.

Patients requiring continued low dose aspirin therapy

• Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy in patients at risk:
  20 mg or 40 mg once daily.

  The therapeutic benefit of esomeprazole 40 mg over esomeprazole 20 mg over the prevention of gastric and/or duodenal ulcers was not demonstrated. Dose of 40 mg can be initiated in patients presented with erosive reflux esophagitis. Refer to posology for erosive reflux esophagitis.

Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole IV solution by intravenous infusion

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is Esomeprazole 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Safety information is limited in doses above 80 mg a day. Clinical trial in adults does not extend beyond 12 months for Esomeprazole doses 80 mg daily or higher. Therefore, physicians who elect to use Esomeprazole in extended periods should periodically re- evaluate the long-term risks and benefits of the drug for the individual patient.

Children below the age of 12 years

Esomeprazole should not be used in children younger than 12 years since no data is available.

Impaired renal function

Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (See “Pharmacokinetic Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired hepatic function

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg Esomeprazole should not be exceeded (See “Pharmacokinetic Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly

Dose adjustment is not required in the elderly.

4.3 Contraindications

Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation.